Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. OSI-PI as a technology enabler Regional Seminar Series Philadelphia Shaun McWeeney Manager, Process Automation/MES Johnson & Johnson October 13, 2009

© Copyright 2009, OSIsoft Inc. All rights Reserved. 2 Empowering Business in Real Time. Impact to Commercial Manufacturing

3 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Objective Agree a J&J wide Enterprise Agreement (EA) with OSI PI for the provision of their process data historian in a cost effective manner. Use the benefits of an OSI PI EA to deploy OSI throughout manufacturing operations to support the roll-out of current Manufacturing Execution System strategies*. Quantify the J&J installations of OSI PI so that we drive the cost of ownership down, manage the supplier globally and leverage resources, knowledge and support globally. Leverage J&J/Microsoft and OSIsoft/Microsoft alliances to deliver enhanced visualisation of process contextualised data. EA should deliver – Site licences at an agreed fixed cost regardless of tag database size. – Agreed professional services and support, potential for managed services. – All available OSI PI application features. – All available OSI PI external system interfaces and a commitment to develop new interfaces required by J&J. *OSI PI has been identified as being a critical enabler for the current GBSC & WWCP MES initiatives

4 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Range of implementation OSI Installation prior to EA – 12 sites across 2 continents representing 9 different J&J affiliates Planned installations following EA – 7 sites across 2 continents Potential installations – 5 sites across 2 continents representing one additional J&J affiliate *OSI PI has been identified as being a critical enabler for the current GBSC & WWCP MES initiatives

Conceptual Architecture & Phased Roll-out Phase 1: Implement for Biologics API & Development (2009/2010) Biologics API: Leiden, Malvern, Manati Biologics Dev: Springhouse, Radnor, Malvern, Schaffhausen Deliver regionally architected infrastructure to support future additions Phase 2: Use EA terms to extend functionality of remaining existing installations Phase 3: Evaluate business case for implementing in pharma

6 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. PI Architecture concept

7 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Advantages of using Data Historians with MES Data Historians acquiring both time-series data and batch context offer a number of Process Performance Analysis functions for: – Single interface to consolidated process data for an MES application. – Real-time production monitoring for early detection and correction of excursions or conditions that can affect product quality. – Detailed process performance analysis for single or multiple batches. – Batch-to-batch and golden batch comparisons. – Batch cycle time analysis. – Support for SPC/SQC and advanced analytics. – Electronic lot release and exception-based reporting against Data Historian and external data, such as LIMS. – Support for equipment maintenance based on usage instead of calendar.

8 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. MES and Data Historian Positioning (S95) Production data collection Production execution management Production resource management Production dispatching Production tracking Production performance Detailed production scheduling Production schedule Product definition management Production level 1-2 functions Production Performance analysis Production capability Product definition Equipment and process specific production rules Equipment and process specific data Operational responses Operational commands MES Functions that Data Historians can participate in

9 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Batch Concept through S95 & S88 Level 4 Level 3 Level 2 Level 1 Level 0 Business Planning & Logistics Plant Production scheduling, Operational Management, etc. Business Planning & Logistics Plant Production scheduling, Operational Management, etc. Manufacturing Operations Management Dispatching Production, Detailed Production Scheduling, Production Tracking, etc. Manufacturing Operations Management Dispatching Production, Detailed Production Scheduling, Production Tracking, etc. Batch Control Batch Control Continuous Control Continuous Control Discrete Control Discrete Control Recipe Procedure Recipe Procedure Recipe Unit Procedure Recipe Unit Procedure Recipe Operation Recipe Operation Recipe Phase Recipe Phase Equipment Phase Equipment Phase Equipment Module Equipment Module Control Module Control Module Out of scope S88 Model Note: This level applies to both Process & Building Management; albeit building management only goes to level 2.2 Phases / Sequences Recipes

10 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. S95 System Architecture Production order status Material consumptions Schedule status Inventory update Master material data Overall inventory Material lot status Production schedule Maintenance schedule Production orders Sample IDs Actual values Process Control System(s) Process Control System(s) ERP MES Material Master Overall Inventory Overall Genealogy Master Batch Record Master Production Schedule Production Orders SAP PM (CMMS) Detailed Production Schedule Production Resource Management Detailed Master Batch Records Production Plan Execution Electronic Batch Recording Weigh & Dispense Review by Exception Material Tracking & Genealogy in Production Inventory Mgt. in Production Deviation & Quality Management Historian (OSI PI) Historian (OSI PI) Training Management Training Management Building Automation System(s) Building Automation System(s) DMS SOP’s / WI’s Drawings Instructions Scales & Printers Scales & Printers LIMS J&J Users (LDAP / AD) J&J Users (LDAP / AD) CAPA Set valuesTelegrams Login verification UserID & PW Doc ID File Manual Interface SynchronizationProcess data Alarm & Events Manual Interface Global MES Local Process data, Batch data, Alarm & Events

© Copyright 2009, OSIsoft Inc. All rights Reserved. 11 Empowering Business in Real Time. Impact to Pharmaceutical Development

12 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Objective Drive development through commercialization with efficiency, consistency, and quality; giving our employees a stronger sense of ownership while continuing to deliver value to our customers by: – Improving transparency, support collaboration & communication – Facilitating enhanced process implementation – Automating repetitive tasks Use the benefits of an OSI PI EA to deploy OSI throughout manufacturing operations to support the roll-out of current Manufacturing Execution System strategies*. Leverage J&J/Microsoft and OSIsoft/Microsoft alliances to deliver enhanced visualisation of process contextualised data. *OSI PI has been identified as being a critical enabler for the current GBSC & WWCP MES initiatives

Lab to Plant Vision Use technology to both simplify & better visualize product development efforts Brx 1 Brx2 Col1 HPLC cIEF CoA UF1 IND Lot1 LIMS SAP Vial Specs IMPA WCB IOQ SEC Process Development Data Analytical Development Data Process Manufacturing Data Analytical Manufacturing Data Data Sources

Lab to Plant Vision Use technology to both simplify & better visualize product development efforts Brx 1 Brx2 Col1 HPLC cIEF CoA UF1 IND Lot1 LIMS SAP Vial Specs IMPA WCB IOQ SEC Process Development Data Analytical Development Data Process Manufacturing Data Analytical Manufacturing Data Process Tech Transfer

Lab to Plant Vision Use technology to both simplify & better visualize product development efforts Brx 1 Brx2 Col1 HPLC cIEF CoA UF1 IND Lot1 LIMS SAP Vial Specs IMPA WCB IOQ SEC Process Development Data Analytical Development Data Process Manufacturing Data Analytical Manufacturing Data Product Release

Lab to Plant Vision Use technology to both simplify & better visualize product development efforts Brx 1 Brx2 Col1 HPLC cIEF CoA UF1 IND Lot1 LIMS SAP Vial Specs IMPA WCB IOQ SEC Process Development Data Analytical Development Data Process Manufacturing Data Analytical Manufacturing Data BLA

17 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method Control over Process Data Management Challenge

18 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab Data Management Challenge Most data Product charac’n data Sparse data

19 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab BLA/NDA, PAIs Comm Lot Release Annual Stability SPC/Trending Data Management Challenge

20 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab BLA/NDA, PAIs Comm Lot Release Annual Stability SPC/Trending INDs Clin Lot Release IND & Reg Stability Data Management Challenge

21 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab BLA/NDA, PAIs Comm Lot Release Annual Stability SPC/Trending INDs Clin Lot Release IND & Reg Stability Tech Transfer PD Reports Dev Stability Data Management Challenge

22 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab BLA/NDA, PAIs Comm Lot Release Annual Stability SPC/Trending INDs Clin Lot Release IND & Reg Stability Tech Transfer PD Reports Dev Stability QbD – Design Space Process & Product Knowledge Data Management Challenge

23 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab Data Management Challenge Needs: Controlled Reports or queries Master Data Strategy Enterprise Solutions

24 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Control over Analytical Method DevQualifiedValidated Control over Process Validated Clin Mfg Dev Lab Data Management Challenge Needs: Controlled Reports or queries Master Data Strategy Enterprise Solutions Needs: Ad hoc querying Able to read/ref all data Data/model Standards Ease of configuration

Information Therapeutic Product Reg Filings, PAIs & Approvals Released Product at Sites System Integration Challenge

26 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Centocor: Springhouse & Radnor

27 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Sharepoint Visualization of PIMS

28 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Sharepoint Visualization of PIMS

29 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Filename 29 Cooking using RES (Recipe Execution System) and PIMS (Production Information Management System) If ERP put everything in the pantry, we’re ready to cook List of Ingredients Procedure on recipe card Oven Oven Temperature Did I make this last time? How did I do it last time? Why did I burn it last time? What spice did I put in? RES: Raw Materials RES: Procedure RES: Equipment RES: Parameters PIMS: Batch List PIMS: Previous batch steps PIMS: Previous batch data PIMS: Previous batch raw materials

30 Empowering Business in Real Time. © Copyright 2009, OSIsoft Inc. All rights Reserved. Recipe Concept supported by OSI - PI

Thank you © Copyright 2009 OSIsoft, Inc. 777 Davis St., Suite 250 San Leandro, CA 94577